510(k) K933125
- Device
- BERICHROM ANTITHROMBIN III (A)
- Applicant
- BEHRING DIAGNOSTICS, INC.
- 510(k) number
- K933125
- Product code
- JPE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-04-19
- Date received
- 1993-06-28
- Regulation
- 864.7060
- Classification name
- Antithrombin Iii, Two Stage Clotting Time Assay
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LORI BARANAUSKAS
- Address
- 151 University Ave. Westwood MA US 02090 02090
FDA Registration Numbers#
- 9610806
Source Documents#
Legacy Summary#
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FDA Review#
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